Amendments To The Cabinet Of Ministers Of 17 January 2006 Rules No 61 "regulations On The State Agency Of Medicines Of The Public Paid Services Price List"

Original Language Title: Grozījumi Ministru kabineta 2006.gada 17.janvāra noteikumos Nr.61 "Noteikumi par Zāļu valsts aģentūras publisko maksas pakalpojumu cenrādi"

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Cabinet of Ministers Regulations No. 860 in 2011 (8 November. No 66 20) amendments to the Cabinet of Ministers of 17 January 2006 rules No 61 "regulations on the State Agency of medicines of the public paid services price list" Issued in accordance with the law on budget and financial management of the ninth paragraph of article 5 to make the Cabinet on 17 January 2006, rules No 61 "regulations on the State Agency of medicines of the public paid services price list" (Latvian journal, 2006, nr. 20; 2007; 2008, 80 no, 146. no; 2009 200. no; 2010, no. 123, 206) the following amendments: 1. Express the point 1.3 of the annex, the second column "type of service" as follows: "each additional strength or sales packaging, including the replacement of the active substance with another salt, esters, isomers of complex or if the exposure and safety characteristics are not significantly different, and each application for weeds with identical registration dossier, but with a different name of the medicinal product and of the same or a different owner for the registration (multiple submission applying at the same time). "
2. Put the attachment point 2.1.2, the second column "type of service" as follows: "each additional strength or sales packaging, as well as for each application for weeds with identical registration dossier, but with a different name of the medicinal product and of the same or a different registration of owners (for multiple application, log on at the same time)."
3. Put the attachment point 3, the second column "type of service" as follows: "the national procedure for medicinal products authorised in the periodic safety report renewable expertise medicines with the same active substance or active substances equal to one of the registration certificate holder".
4. To make the annex 4.1, 4.2, 4.3, 4.4, 4.5 and 4.6 of the subparagraph as follows: "4.1. minor type I A one change ** 100.00 0.00 100.00 4.2. small changes one type IB variation ** 100.00 0.00 100.00 4.3. significant changes of type II if you need documentation in-depth scientific evaluation of the changes of 300.00 0.00 300.00 4.4. significant changes of type II if not necessary documentation in-depth scientific evaluation of the changes of 150.00 0.00 150.00 4.5. significant changes of type II that are associated with the transfer of the registration certificate (the new owner of the registration certificate and the owner are one and the same person) one change of 100.00 0.00 100.00 4.6. changes in the instructions for use or on the label that are not related to changes in the summary of changes of 100.00 0.00 100.00 "5. Express attachment 5.3, 6.3, 7.1.2, 8.1.2, paragraph 9.1.3. and 9.2.3. the second column" type of service "the following : "for each additional strength or sales packaging, as well as for each application for weeds with identical registration dossier, but with a different name of the medicinal product and of the same or a different registration of owners (for multiple application, log on at the same time)."
6. Replace the introductory part of paragraph 10, the words "security report" with the words "safety message".
7. Put the attachment point of the second 10.1 aisle "type of service" as follows: "medicine with one or several identical active substances".
8. Put the attachment 11.1, 11.2, 11.3, 11.4., 11.5 and 11.6. subparagraph by the following: "I A small 11.1 type changes the little I 100.00 0.00 100.00 11.2. Type B changes changes of 11.3.100.00 0.00 100.00 significant changes of type II if you need in-depth scientific evaluation of the changes of documentation of significant 300.00 0.00 300.00 11.4. Type II changes, you do not need an in-depth scientific evaluation of the changes of documentation of significant 150.00 0.00 150.00 11.5. Type II changes associated with the owner of the registration certificate of a change of one change ** 100.00 0.00 100.00 11.6. changes in the instructions for use or on the label that are not related to changes in the summary of changes of 100.00 0.00 100.00 "9. Replace 11.7.1 11.7.2. Annex and the third column" Unit "," change "with the word" procedure ".
10. paragraph 23 of the annex to be expressed in the following wording: "23. Posted materials, printing 1 page 11 Annex 0.85 0.19 1.04" express 39. point as follows: "39. The annual fee for receiving information from the Latvian register of medicinal products 1 year subscription database 182.60 40.17 222.77 ' 12. paragraph 41 of the annex to be expressed in the following wording:" 41. Pharmaceutical quality control analysis and design of Protocol translation in English 1 Protocol "19.50 4.29 23.79 13. Express 43 annex by the following : "Purified Water 43. quality control (pharmacies) 1 ' 14.19.50 4.29 23.79 express 45 of the annex by the following:" 45. Water microbiological purity control 1 analysis "express 15 Annex 6.50 1.43 7.93 86. paragraph by the following:" 86. medicine registry Gazette 1 book 3.70 0.81 4.51 "16. Annex 87 paragraph be deleted.
17. Amend the introductory paragraph of annex 104 and 104.1 in the words "and their".
18. Annex 104.1.1 be deleted., 104.1.2., 104.1.3., 104.1.4., 104.1.5., 104.1.6., 104.1.7., 104.1.8. and 104.1.9. the second point under "type of service", the words "and their".
19. Express 104.1.10 in annex.) (the second column "type of service" as follows: "medical device manufacturers documentation submitted and contains information on the Latvia produced and already registered medical devices of the type or change production technology and the expertise of the Latvian medical equipment database (LATMED) addition".
20. The deletion of the introduction to the annex of 104.2, the words "and their".
21. Annex 104.2.1 be deleted., 104.2.2., 104.2.3., 104.2.4., 104.2.5., 104.2.6., 104.2.7., 104.2.8. and 104.2.9. the second point under "type of service", the words "and their".
22. Replace the introductory part of paragraph 105 of the annex, the words "and/or" with the word "or".
23. Annex 105.1.1 be deleted., 105.1.2., 105.1.3., 105.1.4., 105.1.5., 105.1.6., 105.1.7., 105.1.8., 105.1.9.,.,., 105.2.1 105.2.2 105.2.3.,.,., 105.2.6 105.2.4 105.2.5., 105.2.7., 105.2.8. and 105.2.9. the second point under "type of service", the words "and their".
24. in annex 109. Deleted the second column "type of service", the words "authorization of" submitted.
25. Make note of the annex as follows: "notes". 
1. Value added tax does not apply, in accordance with the law "on value added tax" in article 2, and the twenty-second part of article 6, first paragraph, point 9.1.
2. the State Agency of medicines shall: 2.1 give discount 70% of the amount registered in the evaluation of medicinal products, changes in each subsequent registration number that included a change in the group one in the framework of the change if the change request is filed at the same time in the same application;
2.2. provide discount 70% of the amount registered in the evaluation of medicinal products, changes in each subsequent registration number one changes, if the change request is filed at the same time in the same application;
2.3. payment for such interrelated changes that clearly follows from the basic changes that are submitted in accordance with this annex, or of paragraph 11 4, shall not apply if the change request is filed at the same time in the same application and is the relationship between all resulting changes. "
Prime Minister v. Minister of health I dombrovsky. Cricket»

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